Opioid Use DisorderPhase 1NCT05143424
Evaluation of the Interactions of Cannabidiol (CBD) With Morphine
A Phase 1 study testing Morphine Sulfate in people with Opioid Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to analyze drug-drug interactions of CBD on co-administered Morphine as first step in understanding CBD-opioid interactions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Morphine Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 1 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures.
- Males and females 18 to 55 years of age, inclusive.
- Body mass index (BMI) ranging from 18 to 34 kg/m2, inclusive, and body weight of 56 kg and above.
- Adequate venous access as assessed by an investigator at screening.
- No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
- Recreational opioid use (i.e., defined as prescription opioid use for nontherapeutic purposes on at least 3 occasions within the previous year and at least once in the 12 weeks prior to screening), experienced in using opioids of approximately 30 mg morphine equivalents and not seeking treatment for Opioid Use Disorder.
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- If of childbearing potential, a female study subject must agree to use 1 of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study and for at least 30 days after the last dose of the study medication
- An acceptable method of contraception includes abstinence from heterosexual intercourse or intrauterine device (with or without hormones)
- OR agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication. Oral contraceptives are prohibited.
- If a female of non-childbearing potential, she should be surgically sterile (i.e., has undergone compete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by FSH level.
- A male study subject must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.
- Agree not to ingest alcohol, drinks containing caffeine >500 mg/day (e.g., Coca Cola®, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
- Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
- Must be willing and able to abide by all study requirements and restrictions.
Who cannot join
- Contact site directly for more information
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
AltaSciences
Overland Park, Kansas, 66212
Debra Kelsh, MD, 913-696-1601, contact@altasciences.com
Debra Kelsh, MD
About this study
Official title: Phase 1 Drug-drug Interaction of Cannabidiol and Morphine in Recreational Opioid Users
The purpose of this study is to analyze drug-drug interactions of CBD on co-administered Morphine as first step in understanding CBD-opioid interactions.
Read the detailed description
This is an inpatient, single-blind, non-randomized, 1-sequence study involving healthy subjects who have used opioids for recreational use. The primary objective of the study is to establish the pharmacokinetic parameters of morphine 30 mg when administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
- Conditions
- Opioid Use Disorder
- Being tested
- Morphine Sulfate
- Keywords
- Marijuana Abuse, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders, Central Nervous System Depressants, Psychotropic Drugs, Neurotransmitter Agents, Cannabidiol, CBD, Morphine, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- Opioid-Related Disorders, Marijuana Abuse, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Also called Placebo oral capsule, Placebo
Morphine sulfate 30 mg tablets as a single dose twice
| Study group | Role | What they receive |
|---|---|---|
| CBD (350 mg) | Active comparator | CBD 350 mg twice per day for 3 days Receives: Drug: Morphine Sulfate |
| CBD (700 mg) | Active comparator | CBD 700 mg twice per day for 3 days Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD
Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Measured: 3 day
Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD
Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Measured: 3 day
Establish the Area Under the Curve from zero to infinity (AUC 0-inf) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD
Establish the Area Under the Curve from zero to infinity (AUC 0-inf) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Measured: 3 day
Secondary outcomes (10)
Establish the Time of Maximum Plasma Concentration (Tmax) of morphine when administered orally with and without CBD
Establish the Time of Maximum Plasma Concentration (Tmax) of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Measured: 3 day
Establish the Terminal Phase Elimination Rate Constant of morphine when administered orally with and without CBD
Establish the Terminal Phase Elimination Rate Constant of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Measured: 3 day
Establish the Apparent Clearance of morphine when administered orally with and without CBD
Establish the Apparent Clearance of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Measured: 3 day
Establish the Maximum Plasma Concentration (Cmax) of CBD when administered orally with morphine
Establish the Maximum Plasma Concentration (Cmax) of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine
Measured: 3 day
Establish the Time of Maximum Plasma Concentration (Tmax) of CBD when administered orally with morphine
Establish the Time of Maximum Plasma Concentration (Tmax) of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine
Measured: 3 day
Establish the Area Under the Curve of the dosing period of CBD when administered orally with morphine
Establish the Area Under the Curve of the dosing period of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine
Measured: 3 day
Establish the Apparent Clearance of CBD when administered orally with morphine
Establish the Apparent Clearance of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine
Measured: 3 day
Establish the terminal half-life of CBD when administered orally with morphine
Establish the terminal half-life of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine
Measured: 3 day
Establish the terminal-phase elimination rate constant of CBD when administered orally with morphine
Establish the terminal-phase elimination rate constant of CBD 350 mg b.i.d. and CBD 700 mg b.i.d. when administered orally with morphine
Measured: 3 day
Safety and Tolerability of morphine when administered orally with or without CBD by collecting vital signs and recording treatment emergent adverse events
Incidence of treatment Emergent Adverse Events using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms, its relationship to the treatment, and maximum severity, either reported by the subject or by clinically significant abnormal findings on:
- Physical examination ii. Rate of change in vital signs assessments of heart rate, sitting blood pressure, respiration rate, and temperature iii. Rate of change in ECG assessment iv. Rate of change in venous CO2 concentrations v. Rate of clinical laboratory changes
Measured: 7 + 3/5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start4 Nov 2021
- Primary completion1 Sep 2023
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143424
- Sponsor's protocol ID
- NIDA-CBD-Phase1a-002
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2021
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Drug-drug Interaction of Cannabidiol and Morphine in Recreational Opioid Users
- ClinicalTrials.gov ID
- NCT05143424
- Acronym / sponsor ID
- NIDA-CBD-Phase1a-002
- Conditions
- Opioid Use Disorder
- Keywords
- Marijuana Abuse, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders, Central Nervous System Depressants, Psychotropic Drugs, Neurotransmitter Agents, Cannabidiol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyze drug-drug interactions of CBD on co-administered Morphine as first step in understanding CBD-opioid interactions.
Detailed description
This is an inpatient, single-blind, non-randomized, 1-sequence study involving healthy subjects who have used opioids for recreational use. The primary objective of the study is to establish the pharmacokinetic parameters of morphine 30 mg when administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD (350 mg) | Active comparator | Drug: Morphine SulfateCBD 350 mg twice per day for 3 days |
| CBD (700 mg) | Active comparator | Drug: Morphine SulfateCBD 700 mg twice per day for 3 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures.
- Males and females 18 to 55 years of age, inclusive.
- Body mass index (BMI) ranging from 18 to 34 kg/m2, inclusive, and body weight of 56 kg and above.
- Adequate venous access as assessed by an investigator at screening.
- No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
Key exclusion criteria (1 listed)
- Contact site directly for more information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine SulfateAlso: Placebo oral capsule, PlaceboMorphine sulfate 30 mg tablets as a single dose twice | Drug | CBD (350 mg), CBD (700 mg) |
Primary outcome
Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD
Time frame: 3 day
Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD
Time frame: 3 day
Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
Establish the Area Under the Curve from zero to infinity (AUC 0-inf) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD
Time frame: 3 day
Establish the Area Under the Curve from zero to infinity (AUC 0-inf) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD 350 mg b.i.d. and CBD 700 mg b.i.d.
10 secondary outcomes
Establish the Time of Maximum Plasma Concentration (Tmax) of morphine when administered orally with and without CBD
Time frame: 3 day
Establish the Terminal Phase Elimination Rate Constant of morphine when administered orally with and without CBD
Time frame: 3 day
Establish the Apparent Clearance of morphine when administered orally with and without CBD
Time frame: 3 day
Establish the Maximum Plasma Concentration (Cmax) of CBD when administered orally with morphine
Time frame: 3 day
Establish the Time of Maximum Plasma Concentration (Tmax) of CBD when administered orally with morphine
Time frame: 3 day
Establish the Area Under the Curve of the dosing period of CBD when administered orally with morphine
Time frame: 3 day
Establish the Apparent Clearance of CBD when administered orally with morphine
Time frame: 3 day
Establish the terminal half-life of CBD when administered orally with morphine
Time frame: 3 day
Establish the terminal-phase elimination rate constant of CBD when administered orally with morphine
Time frame: 3 day
Safety and Tolerability of morphine when administered orally with or without CBD by collecting vital signs and recording treatment emergent adverse events
Time frame: 7 + 3/5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Morphine Sulfate in people with Opioid Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debra Kelsh, MD (913-696-1601, contact@altasciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD (time frame: 3 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.